Biopharmaceutical development leaders are rethinking how they manufacture biologics, focusing on quality and higher productivity so that potentially life-saving therapeutics can reach more patients faster and more affordably.

In its effort to address those needs, Just – Evotec Biologics is striving to set a standard for efficiency, innovation, and accessibility. With a mission to help customers bring antibodies and next-generation biologics to market faster and at a lower cost, the company has developed an approach that integrates advanced technologies, sustainable practices, and a deep understanding of regulatory requirements. At the heart of this transformation is the company’s J.DESIGN service and J.POD® manufacturing platform, which together redefine how biologics are designed, optimized, and produced.

Traditional biomanufacturing processes – such as fed-batch production – rely on large bioreactors and complex infrastructure. Just – Evotec Biologics has reimagined this model by scaling down operations to a more manageable and efficient size. At the core of this transformation is the company’s J.DESIGN platform, which integrates AI/ML-driven antibody selection and optimization, high-expression cell lines, and continuous manufacturing infrastructure to support every phase of biologics development – from design and optimization to commercial production.

Just – Evotec Biologics’ intensified continuous manufacturing process utilizes 500 – 2000 L single-use bioreactors that consistently produce between 4-5 /L/day enabling 15-25 day runs that match the output of 10,000 – 30,000 L stainless steel bioreactors used in traditional fed-batch systems. This approach sharply reduces Just – Evotec

Biologics facility’s footprint, water use, and energy consumption - aligning with high environmental, social, and governance (ESG) standards.

The company’s Seattle-area J.POD facility occupies only 130,000 square feet and was designed to support seamless transitions from early-phase clinical trials to late-phase and commercial production. Unlike traditional methods that often require facility and equipment changes during scale-up, the Just -Evotec Biologics technology relies on running the same process for longer durations or at slightly higher volumes for phase-appropriate production needs and streamlines the path to regulatory approval. Just - Evotec Biologics is enabling the industry with this technology stack that can be replicated on a greenfield site or incorporated into a customer’s existing manufacturing facility.

Just – Evotec Biologics can continuously purify antibodies and recombinant proteins from cell culture bioreactors. This process, enabled by the company’s J.CHO® High Expression System, results in higher mass per cell and superior product quality when compared to fed-batch processes. By continuously extracting drug substance from the biological environment, the company preserves the structure and quality attributes of complex biologics, such as bispecifics and Fc fusion proteins, which are highly susceptible to degradation in traditional systems. This capability is particularly valuable for the development of biosimilars and monoclonal antibodies (mAbs). The high productivity of Just’s cell-culture environment enables the production of large quantities of material at a lower cost.

The explosion of unique targets and molecule designs enabled by scientific breakthroughs and AI-driven drug discovery has created unprecedented opportunities in biomanufacturing. However, many of these new molecules cannot be produced at scale using traditional fed-batch technology. Just – Evotec Biologics addresses this challenge with a cell line that thrives in a continuous-manufacturing environment. By maintaining cells at a constant density and continuously perfusing them with fresh media, the company ensures that therapeutic proteins are harvested before they can degrade. This approach has been described as “saving molecules from the cutting room floor,” enabling the production of biologics that would otherwise be unfeasible.

The company has partnered with more than 30 organizations on more than 100 programs, spanning a wide range of modalities, including mAbs, bispecifics, Fc fusion proteins, IgG1, and IgG4. Its commitment to collaboration and innovation has made the company a leader in the field, helping to bring life-changing therapeutics to patients around the world.

Just – Evotec Biologics’s expertise in regulatory filings and large-pharma experience positions the company as a trusted partner for government agencies and organizations responding to global health crises. During the COVID-19 pandemic, Just – Evotec Biologics collaborated with the Gates Foundation, the Biomedical Advanced Research and Development Authority (BARDA), and the US Department of Defense to rapidly produce emergency supplies of biological drugs.

Looking ahead, Just – Evotec Biologics is focused on further enhancing efficiency and accessibility in biomanufacturing. One of the company’s key initiatives is its development of a “productized” approach to continuous manufacturing through its J.Train technology. This concept involves integrating the platform into the infrastructure of other industry participants, including large pharmaceutical companies and contract development and manufacturing organizations (CDMOs). By providing design, intellectual property, and technical expertise, Just – Evotec Biologics aims to enable others to achieve the same operational efficiency seen in its own facilities.

The company is also investing in the development of cell lines and perfusion media optimized for continuous manufacturing. These advancements will support the production of increasingly complex biologics and help customers reach their investigational new drug (IND) milestones faster. Additionally, Just – Evotec Biologics is on track to manufacture FDA-approved commercial drug substances within the next year, further solidifying its role as a leader in the industry.

The biomanufacturing industry is at a crossroads, facing challenges such as high R&D costs, scaling difficulties, supply-chain vulnerabilities, and talent shortages. Just – Evotec Biologics is addressing these issues through continual innovation, building smaller facilities that can be constructed efficiently. The company’s intensified processes and fully continuous manufacturing approach reduces materials and costs while enabling scale-up from bench to full production.

Beyond its technological advancements, Just– Evotec Biologics is committed to fostering the next generation of talent. The company invests in academic programs, supports STEM outreach in local high schools, and collaborates with regulatory agencies, industry consortiums, and other partners to drive innovation and efficiency across the sector.

Just – Evotec Biologics strives to redefine what is possible in biomanufacturing. By combining cutting-edge technology, sustainable practices, and a customer-centric

approach, it is working to improve the efficiency and cost-effectiveness of biologics production while helping new therapies reach patients faster. As the industry continues to evolve, Just – Evotec Biologics is poised to play a pivotal role in shaping its future, ensuring that lifechanging medicines are accessible to those who need them most.